The Determination and Control of Genotoxic Impurities in APIs - Pharmaceutical Technology

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The Determination and Control of Genotoxic Impurities in APIs
The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.


Pharmaceutical Technology
Volume 35, pp. s24-s30

References

1. ICH, S2 (R1) Guideline on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (2008).

2. T. McGovern and D.J. Kram, Trends Analyt. Chem. 25 (8), 790–795 (2006).

3. ICH, Q3A (R2) Guideline on Impurities in New Drug Substances (2006).

4. ICH, Q3C(R4) Guideline for Residual Solvents (2009).

5. R. Kroes et al., Food Chem. Toxicol. 42 (1), 65–83 (2004).

6. EMA, Guideline on the Limits of Genotoxic Impurities (London, January 2007).

7. EMA, Guideline on the Limits of Genotoxic Impurities (February 2009).

8. L. Muller et al., Regul. Toxicol. Pharmacol. 44 (3), 198–211 (2006).

9. M. Sun, D.Q. Liu, and A.S. Kord, Org. Process Res. Dev. 14 (4), 977–985 (2010).

10. D.Q. Liu, M. Sun, and A.S. Kord, J. Pharm. Biomed. Anal. 51 (5), 999–1014 (2010).

11. D.Q. Liu et al., J. Pharm. Biomed. Anal. 50 (2), 144–150 (2009).

12. N.V.V.S.S. Raman et al., J. Pharm. Biomed. Anal. 48 (1), 227–230 (2008).

13. D.P. Elder et al., J. Pharm. Sci. 99 (7), 2948–2961 (2010).

14. L. Bai et al., J. Chromatogr. A 1217 (3), 302–306 (2010).

15. E.J. Delaney, Regul. Toxicol. Pharmacol. 49 (2), 107–124 (2007).

16. K. Ramakrishna, J. Pharm. Biomed. Anal. 46 (4), 780–783 (2008).

17. R. Alzaga et al., J. Pharm. Biomed. Anal. 45 (3), 472–479 (2007).

18. N.V.V.S.S. Raman et al., Talanta 77 (5), 1869–1872 (2009).

19. A. Teasdale, Org. Process Res. Dev. 13 (3), 429–433 (2009).

20. F.N. Onyezili, Analyst 114 (1), 789–791 (1989).


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